MAUDE Adverse Event Report: AZIYO BIOLOGICS INC. CANGAROO ENVELOPE; MESH, SURGICAL - FTM

Model Number CMCV-009-XLG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the cangaroo envelope device history record for the reported lot shows that all packaged and labeled units were quality released to distribution on 06/10/2019 having met all internal qc acceptance requirements.All sterilization processing records and bioburden testing indicate a successful sterilization cycle and passing results of product lal and sterility samples allowing the subassembly lot to be released for further packaging and labeling having met all criteria for release.There were no non-conformances during manufacturing or sterilization potentially impacting the final acceptance of this manufacturing lot.In lieu of a request for the oem supplier dhr review, it is noted that aziyo processes the non-sterile envelope materials including cutting, suturing, packaging and sterilizing the product.It is also noted that per the instructions for use (ifu - art-20662) provided with the finished cangaroo envelope device, infection is listed as a potential complication associated with the procedure and device.Although the exact cause of the reported infection cannot be conclusively determined, infection is a known complication associated with the use of a cangaroo envelope and a surgical implant procedure.Should aziyo receive any additional details related to this event, a supplemental report will be filed.

Event Description

It was reported by aziyo biologics' business partner boston scientific, that a cangaroo envelope (model # cmcv-009-xlg, lot# m19f1231), implanted on (b)(6) 2019, was part of a system explant due to infection.Explant date, explanting physician and the facility where the explant procedure took place were not provided as there was no boston scientific representative present during the procedure.Boston scientific awareness date was (b)(6) 2020.The issue was reported to aziyo biologics on 7/30/2020.

• Brand Name: CANGAROO ENVELOPE
• Type of Device: MESH, SURGICAL - FTM
• Manufacturer (Section D): AZIYO BIOLOGICS INC.; 1100 old ellis road; ste 1200; roswell, ga
• Manufacturer (Section G): AZIYO BIOLOGICS INC.; 1100 old ellis; ste 1200; roswell, ga
• Manufacturer Contact: michael hennick ; 1100 old ellis road; ste 1200; roswell, ga ; 5144023
• MDR Report Key: 10460795
• MDR Text Key: 214409870
• Report Number: 3005619880-2020-00042
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00859389005072
• UDI-Public: 00859389005072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: CMCV-009-XLG
• Device Lot Number: M19F1231
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention